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In Brief: Trex Medical

This article was originally published in The Gray Sheet

Executive Summary

Trex Medical: Becomes the first to submit a 510(k) for a full-field digital mammography system, Trex announces Dec. 1 at the Radiological Society of North America annual conference in Chicago. The 510(k) includes data on 520 women and about 4,000 breast images to show that the digital system is equivalent to current film-screen technology. Trex anticipates launching the system in the U.S. in 1998, initially through beta site testing at 10-12 centers. The company has not yet decided whether it will pursue additional trials to determine whether its digital system is superior to film-screen mammography...
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